Tag: GeoVax Labs

Research News and Market Data on GOVX

 

Manufacturing Process for Phase 3 and Commercial Production

Being Developed for GeoVax MVA-Based Vaccines

Atlanta, GA, March 6, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced a significant milestone toward implementation of a validated chicken embryonic fibroblast (CEF) based production system for the company’s MVA-based vaccines, with the release of its first lot of GEO-CM04S1 (next-generation Covid-19 vaccine) produced with a commercial manufacturing platform. This milestone marks the successful completion of the transfer and scale-up of manufacturing from the research-focused Center for Biomedicine & Genetics at City of Hope (Duarte, CA) to the experienced CDMO ABL Europe (a subsidiary of Oxford Biomedica), the Company’s cGMP (current Good Manufacturing Procedures) manufacturing partner.

David Dodd, GeoVax President and CEO, commented, “The successful establishment of cGMP production at ABL Europe represents great progress for GeoVax and the CM04S1 program. This latest manufacturing milestone also validates our choice of ABL Europe as our partner for cGMP production of our MVA-based vaccine candidates. This gives us a high degree of confidence in our manufacturing process as we move into late-stage clinical development for CM04S1, addressing a critically important unmet medical need for immunocompromised populations.”

Dodd continued, “While we continue the use of CEF-based production for our CM04S1 clinical programs, it is important to also recognize the significant advancements made in our commercial-scale production capabilities. Our multi-product license of ProBioGen’s AGE1.CR.PIX® suspension cell line enhances our capacity to produce MVA-based vaccines (including CM04S1 and GEO-MVA) and immunotherapies at an unprecedented scale. These developments signify GeoVax’s commitment to improving vaccine accessibility through cost-effective and scalable manufacturing processes.”

About GEO-CM04S1

GEO-CM04S1 is a next-generation Covid-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. CM04S1 presents both the spike and nucleocapsid antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to non-variable parts of the virus. The more broadly specific and functional engagement of the immune system is designed to protect against the continually emerging variants of Covid-19. Results released during 2023 demonstrated the safety and efficacy of CM04S1 and emphasize the role it will play in protecting immunocompromised patients from greater risk of severe disease, hospitalization and death from SARS-CoV-2 infection.

About GEO-MVA

In response to the global need to address the continued emerging threat from Mpox (monkeypox), GeoVax previously announced having secured rights from the National Institutes of Health (NIH) covering preclinical, clinical and commercial uses of the NIH-MVA as a vaccine against Mpox or smallpox.  The Company is currently pursuing different regulatory pathways toward achievement of an expedited approval and intends to become the first U.S.-based supplier of the MVA vaccine to prevent Mpox and smallpox.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation Covid-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized Covid-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable Covid-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

 Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:		Investor Relations Contact:		Media Contact:
info@geovax.com		paige.kelly@sternir.com		sr@roberts-communications.com
678-384-7220		212-698-8699		202-779-0929

Research News and Market Data on GOVX

Progress across the pipeline in multiple clinical trials, including

Phase 2 program of GEO-CM04S1, next-generation Covid-19 vaccine, and

multicenter Phase 1/2 study of Gedeptin^®, targeting advanced head and neck cancer

Catalyst-rich 2024 with data readouts planned throughout the year

Company to host conference call and webcast today at 4:30 p.m. ET

ATLANTA, GA, February 29, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced its financial results and key operational accomplishments for the year ended December 31, 2023.

 “2023 marked another year of advancement of our ongoing clinical programs for GEO-CM04S1, our next-generation Covid-19 vaccine, and for Gedeptin^® in cancer therapy,” stated David Dodd, GeoVax’s Chairman and CEO. “This past year, we completed enrollment for the Phase 2 clinical trial assessing GEO-CM04S1 as a universal booster for the mRNA Covid vaccines, while expanding to multiple sites for our Phase 2 trial among immunocompromised/stem cell transplant patients, evaluating GEO-CM04S1 as a primary vaccine, in direct comparison to mRNA vaccines.  In addition, the third Phase 2 trial of GEO-CM04S1 was initiated, evaluating our vaccine among immunocompromised/Chronic Lymphocytic Leukemia patients as a booster for such patients having initially received a mRNA vaccine, also in a direct comparison to a mRNA vaccine.

“Results released during 2023 demonstrated the safety and efficacy of GEO-CM04S1 and emphasize the role it will play in protecting immunocompromised patients from greater risk of severe disease, hospitalization and death from SARS-CoV-2 infection,” Dodd continued. “Perhaps of most importance, the results to date have demonstrated potential protective immunity of GEO-CM04S1 against multiple strains of SARS-CoV-2, from the ancestral Wuhan strain through Delta and the highly virulent Omicron XBB.1.5, without the need for vaccine reconfiguration.  This critically important potential feature appears unique to our Covid-19 vaccine.”

Dodd concluded, “Relative to our oncology progress, GeoVax completed enrollment for the Phase 1/2 clinical trial of Gedeptin among advanced head and neck cancer patients. Results to date have demonstrated safety of this therapy and consistent reduction in treated tumors.  During first half 2024, we anticipate reporting additional results from the Gedeptin Phase 1/2 clinical trial, as well as our plans for an expanded Phase 2 clinical trial.  Overall, these achievements can be attributed to the successful execution of our long-term strategy, with an end goal to bring unique, patented products to market, addressing unmet medical needs. We look forward to reporting further progress in these studies and are encouraged to be entering into a data-rich 2024.”

 2023 Clinical Trial Progress and Operational Developments

 GEO-CM04S1

• Enrollment completed for the Phase 2 clinical trial assessing GEO-CM04S1 as a potential universal booster for patients previously vaccinated with Pfizer or Moderna vaccines. The data presented during this period showcased promising results, indicating the potential of GEO-CM04S1 as a versatile Covid-19 vaccine capable of providing immunity against various strains, including the Wuhan, Delta, and Omicron variants. The trial involves 63 healthy adults who previously received mRNA vaccines as their primary vaccine. The data showed no serious adverse events and significant increases in neutralizing antibody, as well as cellular immune responses against multiple SARS-CoV-2 variants. Final results from this trial are anticipated during the fourth quarter of 2024.
• Initiation of a Phase 2 booster trial targeting immunocompromised patients with chronic lymphocytic leukemia (CLL), who typically have reduced immune responses to mRNA vaccines due to their medical condition. This investigator-initiated trial expects to enroll 80 patients and directly compare GEO-CM04S1 with the Pfizer/BioNTech Bivalent vaccine. Results from an interim analysis are anticipated during the first half of 2024.
• Data presentations from the immunocompromised/stem cell transplant patient Phase 2 trial of GEO-CM04S1 at the World Vaccine Congress, as well as initial results published in the peer-reviewed journal, Vaccines. The findings demonstrated robust immunogenicity, illustrating the vaccine’s ability to induce both antibody and T cell responses, essential for conferring protection, particularly in immunocompromised individuals. The article also highlighted the unique feature of GEO-CM04S1 providing protective immune levels from the ancestral Wuhan strain through Delta and the highly virulent Omicron XBB.1.5 variant. This study has been expanded to a multi-site trial, with further results anticipated throughout 2024.

Gedeptin^®

• Completion of patient enrollment for the Phase 1/2 clinical trial of Gedeptin among advanced head and neck cancer patients. The data presented at the AACR-AHNS Head and Neck Cancer Conference emphasized the safety and feasibility of Gedeptin therapy, providing insights into its potential as a treatment option for patients with limited therapeutic alternatives. The initial Phase 1/2 trial aims to guide future studies, potentially expanding the application of Gedeptin in other solid tumor areas and in combination with immune checkpoint inhibitors. During 2024, we expect to announce plans relative to an expanded Phase 2 study among advanced head and cancer patients, following discussions with regulatory authorities. In addition, we plan to outline plans for further Gedeptin clinical development, both in additional monotherapy and in combination-therapy (e.g., Gedeptin + immune-checkpoint inhibitor) indications. 

Advanced Vaccine Manufacturing Process

• Significant advancements made in MVA manufacturing capabilities focused on implementing a transformative manufacturing process in support of MVA-based vaccines and immunotherapies. The multi-product license with ProBioGen involving the AGE1.CR.PIX® suspension cell line enhances GeoVax’s capacity to produce MVA-based vaccines and immunotherapies at an unprecedented scale. Additionally, the agreement with Advanced Bioscience Laboratories, Inc. (ABL) secures cGMP production capabilities in support of GeoVax transitioning to worldwide commercialization capability. These developments signify GeoVax’s commitment to improving vaccine accessibility through cost-effective and scalable manufacturing processes.  Our intent is to successfully develop our products for worldwide commercialization and distribution, in conjunction with partnering and collaborative relationships.

Corporate and Intellectual Property Developments

•  Achieved notable milestones in intellectual property development, securing multiple patents covering a range of vaccine candidates. The expanded rights under the NIH Covid-19 license to include Mpox and smallpox further diversify GeoVax’s vaccine portfolio, potentially offering broader protection against infectious diseases. Additionally, the issuance of patents for Ebola, Marburg, Malaria, and HIV vaccines underscores GeoVax’s innovative approach to vaccine development and its dedication to advancing global health initiatives. As of February 2024, the following actions were taken by global patent offices, further strengthening the Company’s intellectual property assets:

• The Japanese Patent Office issued a Decision of Grant notifying GeoVax of the allowance of the Company’s Patent Application No. 2022-153352 titled “Compositions and Methods for Generating an Immune Response to a Tumor Associated Antigen.” The allowed claims are directed to recombinant MVA viral vectors comprising specific MUC-1 nucleic sequences used in GeoVax’s MUC-1 tumor-associated antigen immunotherapy program. Pharmaceutical compositions for inducing immune responses, preventing or reducing neoplasm growth, or treating cancer are also covered by the granted claims.
• The U.S. Patent and Trademark Office issued Patent No. 11,896,657 to GeoVax, pursuant to the Company’s patent application No. 17/584,231 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40).” The allowed claims generally cover GeoVax’s vector platform for expressing Marburg virus antigens in virus-like particles (VLPs) utilizing an MVA viral vector.
• The U.S. Patent and Trademark Office issued Patent No. 11,897,919 pursuant to the Company’s patent application No. 17/409,574 titled “Multivalent HIV Vaccine Boost Compositions and Methods of Use.” The allowed claims generally cover a priming vaccination with a DNA vector encoding multiple HIV antigens in virus-like particles (VLPs), followed by a boost vaccination with GeoVax’s vector platform for expressing HIV-1 antigens in VLPs utilizing an MVA viral vector.
• Appointed J. Marc Pipas, M.D., as Executive Medical Director, Oncology. Dr. Pipas has extensive clinical, research, and leadership expertise in oncology, built on a long and successful academic career at Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center, an NCI Comprehensive Cancer Center. He brings a deep understanding of oncologic therapeutics and clinical trial management, as well as a network of research contacts and leadership skills honed by many years of experience.

 2023 Full Year Financial Results

Net Loss: Net loss for the year ended December 31, 2023, was $26.0 million, as compared to $14.0 million for the year ended December 31, 2022.

R&D Expenses: Research and development expenses were $20.7 million for 2023, compared to $9.1 million in 2022, with the increase primarily due to the costs of conducting clinical trials for GEO-CM04S1 and Gedeptin, costs of manufacturing materials for use in our clinical trials, technology license fees, personnel costs, costs of preclinical research activities and higher travel costs.

G&A Expenses: General and administrative expenses were $6.0 million for 2023, compared to $5.0 million in 2022, with the increase primarily attributable to higher personnel costs, investor relations consulting costs, legal fees, patent costs and travel expenses.

Cash Position: GeoVax reported cash balances of $6.5 million on December 31, 2023, as compared to $27.6 on December 31, 2022.

Summarized financial information is attached. Further information is included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission.

Conference Call Details

Management will host a conference call scheduled to begin at 4:30 p.m. ET today, February 29, 2024, to review financial results and provide an update on corporate developments. A question-and-answer session will follow management’s formal remarks.

Domestic: (800) 715-9871

International: +1 (646) 307-1963

Conference ID: 3926207

Webcast: https://edge.media-server.com/mmc/p/uo7z87mz

A webcast replay of the call will be available for three months via the same link as the live webcast approximately two hours after the end of the call.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation Covid-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized Covid-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable Covid-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:		Investor Relations Contact:		Media Contact:
info@geovax.com		paige.kelly@sternir.com		sr@roberts-communications.com
678-384-7220		212-698-8699		202-779-0929

FINANCIAL TABLES

Research News and Market Data on GOVX

GeoVax to Host Conference Call at 4:30 PM ET

Atlanta, GA, February 22, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it will report 2023 financial results on Thursday, February 29, 2024, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results.

Dial-in numbers:

Domestic:          (800) 715-9871

International:    +1 (646) 307-1963

Conference ID:  3926207

Webcast:

A webcast of the live call may be accessed here and on the Events page of the GeoVax website. A webcast replay of the call will be available for three months via the same link as the live webcast approximately two hours after the end of the call.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation Covid-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized Covid-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable Covid-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Company Contact:		Investor Relations Contact:		Media Contact:
info@geovax.com		paige.kelly@sternir.com		sr@roberts-communications.com
678-384-7220		212-698-8699		202-779-0929

Research News and Market Data on GOVX

Atlanta, GA, January 29, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the Company’s Board of Directors has approved a reverse stock split of its issued and outstanding shares of common stock, par value $0.001 per share (the “Common Stock”), at a ratio of 1-for-15. The Company is effecting the reverse split to regain compliance with the $1.00 minimum bid price required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The reverse stock split was approved by the Company’s stockholders at a meeting held January 16, 2024.

The reverse stock split will become effective on January 30, 2024 (the “Effective Date”), and the Common Stock is expected to begin trading on the split-adjusted basis on the Nasdaq Stock Exchange (“Nasdaq”) at the market open on January 31, 2024. Following the reverse split, the Common Stock will continue to trade under the symbol “GOVX”, and the Company’s publicly traded warrants will continue to trade under the symbol “GOVXW”.

On the Effective Date, every 15 issued and outstanding shares of the Company’s Common Stock will be converted automatically into one share of the Company’s Common Stock without any change in the par value per share. The total number of issued and outstanding shares of Common Stock will therefore be reduced proportionately from 29,757,823 shares to approximately 1,983,855 shares. On the Effective Date, the publicly traded warrants will be adjusted to require fifteen (15) warrants to be exercised to receive one (1) share of common stock at a price of $75 per share.

Immediately after the reverse stock split, each stockholder’s percentage ownership interest in the Company and proportional voting power will remain unchanged, except for minor changes and adjustments that will result from the rounding up of any fractional shares to the next whole number of shares. The rights and privileges of the holders of shares of Common Stock will be substantially unaffected by the reverse stock split.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:		Investor Relations Contact:		Media Contact:
info@geovax.com		paige.kelly@sternir.com		sr@roberts-communications.com
678-384-7220		212-698-8699		202-779-0929

Research News and Market Data on GOVX

 

 Strengthening GeoVax’s Team Advancing Gedeptin^® Clinical Program

Atlanta, GA, January 8, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the appointment of J. Marc Pipas, M.D., to serve as the Company’s Executive Medical Director, Oncology.

Kelly McKee, M.D., MPH, GeoVax Chief Medical Officer, commented, “Dr. Pipas’ addition to our team represents an important step forward in the strengthening of GeoVax’s organizational and operational resources to support advancement of our principal oncology asset, Gedeptin^®, through clinical development and regulatory approval.  He is also well-positioned to guide the clinical development of GeoVax’s broader immune-oncology portfolio. We are excited to leverage the wealth of knowledge, expertise, and insights he will provide relative to the clinical developments in support of our oncology programs.”

“I am pleased to be joining the GeoVax team,” said Dr. Pipas. “Oncologic research and development is my passion and I look forward to engaging with our clinical researchers, regulatory authorities, and the medical community at large, to advance GeoVax’s mission.”

Dr. Pipas has extensive clinical, research, and leadership expertise in oncology, built on a long and successful academic career at Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center, an NCI Comprehensive Cancer Center.  During his academic career, Dr Pipas led the GI Clinical Oncology Group for >10 years, served as Hematology/Oncology Fellowship Director, was Medical Director for the Office of Clinical Research in the Cancer Center, and served for more than a decade as a member of Human Subject Protection and Data Monitoring Boards. Following his academic career, he held positions of increasing responsibility in the biopharma industry, guiding the development of several novel oncology therapeutics through early- and late-stage clinical trials.

Dr. Pipas received his Doctor of Medicine degree from SUNY-HSC at Syracuse in 1989 and completed a residency in Internal Medicine at the Medical University of South Carolina in Charleston.  Following this, he completed a fellowship in Hematology/Oncology at Dartmouth-Hitchcock Medical Center in New Hampshire and was then invited to become a faculty member at Dartmouth Medical School where he achieved the rank of Full Professor. He has 40 scientific papers and more than 60 abstracts to his credit and has numerous nominations and awards for teaching and humanism in medicine. Dr Pipas brings a deep understanding of oncologic therapeutics and clinical trial management, as well as a network of research contacts and leadership skills honed by many years of experience.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:		Investor Relations Contact:		Media Contact:
info@geovax.com		paige.kelly@sternir.com		sr@roberts-communications.com
678-384-7220		212-698-8699		202-779-0929

Research News and Market Data on GOVX

 

• Last updated: 14 November 2023 14:02
• Created: 14 November 2023 13:23
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Single-Dose Protection Demonstrated Against Multiple SARS-CoV-2 Variants

Atlanta, GA, November 14, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the presentation of preclinical vaccine efficacy data for GEO-CM02, a multi-antigen investigational SARS-CoV-2 vaccine. The data were presented during the Vaccines Summit 2023 conference, being held in Boston, MA on November 13-15, 2023. The presentation, titled “MVA-vectored multi-antigen COVID-19 vaccines induce protective immunity against SARS-CoV-2 variants spanning Alpha to Omicron in preclinical animal models,” was delivered by Mukesh Kumar, PhD, Associate Professor, Department of Biology, Georgia State University.

“We are thrilled to continue to demonstrate the robust efficacy profile of GEO-CM02 with the presentation of preclinical data at this year’s Vaccine Summit,” said David Dodd, GeoVax’s Chairman and CEO. “Together, these data indicate that immunization with the multi-antigen GEO-CM02 vaccine can protect against severe disease and death induced by SARS-CoV-2 infection and regardless of the variant. Along with a demonstrated safety profile, we believe GEO-CM02 has potential as a transformative universal coronavirus vaccine.”

First-generation SARS-CoV-2 vaccines based on the spike (S) protein have demonstrated that they induce neutralizing antibodies, providing effective, albeit short-term levels of immune protection. Unfortunately, with the existing authorized vaccines, efficacy is disrupted by emerging variants that contribute to neutralizing antibody evasion, requiring continuous updating and booster doses. To address this limitation, GeoVax is currently evaluating its dual antigen COVID-19 vaccine, GEO-CM04S1 in three Phase 2 clinical trials.  GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of COVID-19. Vaccines of this format should not require frequent and repeated modification or updating. Moreover, GEO-CM04S1 is being developed specifically as a COVID-19 vaccine in support of patients with compromised immune systems, for whom the current authorized vaccines appear inadequate in providing protective immunity.

GEO-CM02 is a multi-antigen SARS-CoV-2 vaccine, based on the S, membrane (M), and envelope (E) proteins, which are designed to also engage both the humoral (antibody) and cellular (T-cell) arms of the immune system and to broaden both the function and specificity, potentially as a universal coronavirus vaccine. Efficacy of this investigational vaccine was tested using the industry standard, lethal hACE2 transgenic mouse model.

Data highlights from the Vaccine Summit 2023 presentation are as follows:

• The GEO-CM02 vaccine induced immune responses that were efficacious against the original Wuhan strain and BA.1 Omicron variant with a single dose.
• Animals were protected prior to the detection of neutralizing antibodies, likely indicating a critical T-cell contribution.
• GEO-CM02 significantly reduced or eliminated inflammation and immunopathology in the lungs of vaccinated animals.

The data generated in the GEO-CM02 studies validate GeoVax’s hypothesis that vaccines designed to induce both antibodies and T-cells to multiple viral structural proteins can address the issue of viral variation and escape from the immune system. GEO-CM02 is based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose.

GeoVax’s more advanced, next-generation COVID-19 vaccine, GEO-CM04S1, is being evaluated in three ongoing Phase 2 clinical trials:

• As a primary vaccine in immunocompromised patients (with hematologic cancers receiving cell transplants or CAR-T therapy). ClinicalTrials.gov Identifier: NCT04977024. GeoVax recently announced clinical site expansion for this trial.
• As a booster vaccine in immunocompromised patients with chronic lymphocytic leukemia (CLL), a recognized high-risk group for whom current mRNA vaccines and monoclonal antibody (MAb) therapies appear inadequate relative to providing protective immunity. ClinicalTrials.gov Identifier: NCT05672355.
• As a booster vaccine for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine. gov Identifier: NCT04639466. GeoVax recently announced that this trial has fully enrolled.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:		Investor Relations Contact:		Media Contact:
info@geovax.com		paige.kelly@sternir.com		sr@roberts-communications.com
678-384-7220		212-698-8699		202-779-0929

Research News and Market Data on GOVX

 

• Last updated: 08 November 2023 21:03
• Created: 08 November 2023 15:32
• Hits: 505

Significant Progress towards data milestones in Phase 2 Program of GEO-CM04S1, Next-generation COVID-19 vaccine

Gedeptin^® clinical data from Phase 1/2 study presented at AACR-AHNS Head and Neck Cancer Conference showing safe administration and tumor reduction

Multi-Product License Secured for ProBioGen’s AGE1.CR.pIX® suspension cell line to enhance manufacturing capabilities of MVA-based vaccine portfolio

Company to host conference call and webcast today at 4:30 p.m. ET

ATLANTA, GA, November 8, 2023 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced financial results for the third quarter ended September 30, 2023 and provided a business update.

“We are thrilled to see material advancements across all aspects of our business. Through the third quarter, we are delivering on our promise to bring transformative change to the treatment of COVID-19 by completing enrollment in our healthy volunteer Phase 2 clinical trial evaluating GEO-CM04S1 as a potentially more robust, more durable booster vaccine. In addition, with two additional Phase 2 trials ongoing in immunocompromised population, and recent publication of positive safety and potent immunogenicity data in this population, we have strengthened our conviction in the potential of our next-generation COVID-19 vaccine (GEO-CM04S1) for immunocompromised patients. We believe the need for new treatment options for immunocompromised patients in the fight against COVID-19 is significant, particularly as we begin to enter the winter surges of this diseases, where these patients will be left most vulnerable,” said David Dodd, Chief Executive Officer of GeoVax.

“We are preparing to announce initial data readouts from two of our Phase 2 GEO-CM04S1 trials as well as updates from our Gedeptin^® clinical trial against head and neck cancer in the coming months. Earlier this summer, we were delighted to present clinical data which revealed the safe and feasible administration of Gedeptin^®. We believe the Gedeptin mechanism of action to be solid tumor agnostic, and therefore offers the potential as a therapeutic option for multiple cancer types and positions the product for long-term growth. The third quarter of 2023 also saw new patents issued for our Ebola, Marburg, Malaria, and HIV vaccines, demonstrating the strength of our team’s ability to execute on our broader strategy. In addition, we advanced our manufacturing process through the signing of a landmark multi-product commercial license agreement with ProBioGen for the use of their AGE1.CR.PIX^®suspension cell line. We believe that these catalysts altogether will have a profound impact on patients in need and all our stakeholders.”

Recent Business Achievements

GEO-CM04S1

• Enrollment completed for Phase 2 clinical trial evaluating GEO-CM04S1 as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine in September of 2023. An initial data readout is expected soon.

• GEO-CM04S1 demonstrated potent antibody and cellular immunity in immunocompromised patients in a recent publication in the journal, Vaccines, in August 2023. GeoVax’s Phase 2 clinical trial evaluated the safety and immunogenicity of GEO-CM04S1, compared to either the Pfizer/BioNTech or Moderna mRNA-based vaccine in patients who have previously received an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or CAR-T cell therapy. Most promising in the results published was the demonstration of the potential of GEO-CM04S1 as a variant agnostic COVID-19 vaccine, providing potent immunity from the Wuhan through Delta and Omicron strains.
  • In October 2023, GeoVax commenced the planned site expansion for this trial to accelerate patient enrollment. In addition to study enrollments completed at the City of Hope Medical Center (Duarte, California), the trial is now open at Wake Forest Baptist Medical Center (Winston Salem, North Carolina), the University of Massachusetts Medical Center (Worcester, Massachusetts), and Fred Hutchinson Cancer Center (Seattle, Washington).
• Commenced investigator-initiated randomized observer-blinded Phase 2 clinical trial of COVID-19 boosters with GEO-CM04S1 or Pfizer-BioNTech bivalent vaccines in patients with chronic lymphocytic leukemia (CLL) in July of 2023. The trial is rapidly enrolling patients and progressing towards an interim data review. 
• Presented data for GEO-CM02 at the Keystone Symposia Conference in an abstract titled, MVA-vector multi-antigen COVID-19 vaccines induce protective immunity against SARS-CoV-2 variants spanning Alpha to Omicron in preclinical animal models in September of 2023. The data revealed that the GEO-CM02 vaccine induced immune responses that were efficacious against the original Wuhan strain and Omicron variants with a single dose. This effort expands upon GeoVax’s hypothesis that vaccines designed to induce both antibodies and T-cell responses to multiple viral structural proteins can address the issue of viral variation and escape from the immune system without the need for repeated seasonal adjustments.

Gedeptin^®

• Gedeptin^® clinical data presented at the AACR-AHNS Head and Neck Cancer Conference in an abstract titled, Phase 1/2 study of Ad/PNB with Fludarabine for the Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC) in July 2023. The FDA-funded study revealed that the administration of Gedeptin^® is safe and feasible.

Advanced Vaccine Manufacturing Process

• GeoVax and ProBioGen announced the signing of a landmark multi-product commercial license agreement for ProBioGen’s groundbreaking AGE1.CR.PIX^® suspension cell line in September 2023. The agreement enhances the manufacturing capabilities of GeoVax’s entire Modified Vaccinia Ankara (MVA)-based vaccine portfolio with respect to both scale and flexibility. This follows the May 2023 agreement with Advanced Bioscience Laboratories, Inc. (ABL) to support current Good Manufacturing Practices (cGMP) production of the Company’s vaccine candidates. These agreements move the Company toward fully implementing a continuous cell line manufacturing system that will provide lower-cost, scalable versatility for our entire MVA-based vaccine portfolio.

Intellectual Property Developments

• GeoVax recently secured multiple positive patent decisions covering notice of allowances for Ebola, Marburg, Malaria and HIV vaccines.
  • GeoVax announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/584,231 titled patent titled “Replication Deficient Modified Vaccina Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40).”
  • GeoVax announced that the U.S Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/409,574 titled “Multivalent HIV Vaccine Boost Compositions and Methods of Use.”
  • GeoVax announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/726,254 titled “Compositions and Methods for Generating an Immune Response to Treat or Prevent Malaria.”
  • GeoVax announced that the U.S. Patent and Trademark Office has issued Patent No. 11,701,418 B2 to GeoVax, pursuant to the Company’s patent application No. 15/543,139 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) and Matrix Protein (VP40).”

Upcoming Events

• GeoVax will participate in upcoming conferences and industry events:
  • Vaccines Summit 2023, November 13-15, 2023, Boston, MA
  • World Vaccine Congress, West Coast, November 27-30, 2023, Santa Clara, CA
  • NobleCon19, December 3-5, Boca Raton, FL
  • Emerging Growth Conference, December 6-7, Virtual

Third Quarter 2023 Financial Results

Net Loss: Net loss for the three months ended September 30, 2023, was $8,408,818 ($0.32 per share) as compared to $3,968,102 ($0.17 per share) for the comparable period in 2022. For the nine months ended September 30, 2023, the Company’s net loss was $18,374,354 ($0.69 per share) as compared to a net loss of $8,637,316 ($0.63 per share) in 2022.

R&D Expenses: Research and development expenses were $6,947,979 and $14,486,896 for the three-month and nine-month periods ended September 30, 2023, compared to $2,721,196 and $5,358,917 for the comparable periods in 2022, with the increase primarily due to the cost of conducting clinical trials for GEO-CM04S1 and Gedeptin, costs of manufacturing materials for use in our clinical trials, additional personnel costs, technology license fees, costs of preclinical research activities and a generally higher level of activity.

G&A Expenses: General and administrative expenses were $1,651,775 and $4,562,293 for the three-month and nine-month periods ended September 30, 2023, compared to $1,249,337 and $3,363,672 for the comparable periods in 2022, with the increase primarily due to higher personnel costs, investor relations consulting costs, patent costs and other expenses supportive of a higher level of activity.

Cash Position: GeoVax reported cash balances of $12,687,041 at September 30, 2023, as compared to $27,612,732 at December 31, 2023.

Further information is included in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.

Conference Call Details

Management will host a conference call scheduled to begin at 4:30 p.m. ET today, November 8, 2023, to review financial results and provide an update on corporate developments. A question-and-answer session will follow management’s formal remarks.

Domestic: +1-800-715-9871

International: +1-646-307-1963

Conference ID: 7519986

Webcast: https://edge.media-server.com/mmc/p/r4i9d5j7

A webcast replay of the call will be available for three months via the same link as the live webcast approximately two hours after the end of the call.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact:		Investor Relations Contact:		Media Contact:
info@geovax.com		paige.kelly@sternir.com		sr@roberts-communications.com
678-384-7220		212-698-8699		202-779-0929